Senior Quality Engineer

At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact—innovating at the speed of life.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are deployed in hospitals, reference and research laboratories, and physician offices worldwide. Every hour, more than one million tests are run on our systems, impacting 1.2 billion patients and over three million clinicians annually.

About the role

The Senior Quality Engineer ensures the business complies with the Quality Management System and regulations. This on-site position is part of the Instrument Quality organization in Chaska, MN, reporting to the Quality Manager responsible for Instrument Quality.

Responsibilities

• Conduct comprehensive reviews of manufacturing SOPs, document change orders, bills of materials, service manuals, part drawings, material specification sheets, field service manuals, nonconformance records, CAPAs, and other quality records to ensure compliance with the Quality System and regulations.
• Lead Kaizen events to improve transactional processes, reduce process variations, and implement lean processes on the production floor to reduce cycle time, maximize resource utilization, improve associate experience and engagement, and eliminate lean wastes (e.g., correction, overproduction, motion, material movement, waiting, inventory, and process).
• Reduce instrument defects by investigating and evaluating identified issues and implementing countermeasures to prevent recurrence.
• Reduce nonconformances by investigating and evaluating identified issues and implementing countermeasures to prevent recurrence.
• Assess risk associated with:
  • Design changes
  • Internal product non-conformances
  • External post-launch issues
  • Systemic issues of the Quality system or instrument manufacturing business

Requirements

• Engineering degree in a relevant field (e.g., Mechanical, Electrical, Chemical).
• Bachelor’s degree with 5+ years of experience, or Master’s degree with 3+ years of experience, or Doctoral degree with 0–2 years of experience.
• Experience applying Design Controls and Design Changes according to 21 CFR 820 for moderately complex design changes.
• Experience applying Risk Management (ISO 14971) for medical device companies.

Qualifications

Certified Quality Engineering certification is preferred.

Benefits

Beckman Coulter Diagnostics offers a broad array of comprehensive, competitive benefit programs, including:

• Paid time off
• Medical, dental, and vision insurance
• 401(k) retirement plan

Pay

The annual salary range for this role is $90,000–$110,000. This range reflects the company’s good-faith belief at the time of posting and may be modified in the future. The role is also eligible for bonus or incentive pay.